Bayer's blood loss medication Trasylol (aprotinin) is again in the spotlight due to serious safety concerns; FDA issued a MedWatch alert Oct. 25 alerting the healthcare community to new clinical trial data showing that Trasylol was associated with an increased risk of death compared to other antifibrinolytic drugs.

"FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action," the agency said.

Trasylol was already the subject of a September joint meeting of FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees due to concerns over safety. The committees voted to continue marketing of Trasylol, but supported further clinical research (¹ Also see "Joint Panel Favors More Postmarketing Studies For Bayer’s Trasylol" - Pink Sheet, 12 September, 2007.).

Now FDA said the latest data support the results from the other comparison studies reviewed by the advisory committees. The data could precipitate further regulatory action, including updated labeling or more significant steps.

The MedWatch alert came after a data safety monitoring board recommended that Bayer stop enrollment in a Canadian trial, BART, when preliminary findings suggested that aprotinin increased the risk of death. The trial is evaluating Trasylol compared to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery.

"Healthcare professionals who are considering use of Trasylol should be aware of the risks and benefits described in the prescribing information for Trasylol and the accumulating data suggesting Trasylol administration increases the risk of death compared to other antifibrinolytic drugs," FDA says.

The full data has not yet been shared with Bayer, the drug maker said. The company notified FDA, Health Canada and other regulatory authorities immediately after being alerted to the data, which in addition to risk of death also indicated that Trasylol reduced bleeding. The company said it expects an ongoing analysis of the data to take between four and eight weeks.

"Consequently, no further evaluation either by Bayer or by regulatory authorities can take place until additional information becomes available from the BART investigators," Bayer said. The company said it believes Trasylol remains a safe and effective treatment.

Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

BART is a blinded, randomized controlled trial evaluating Trasylol compared to aminocaproic and tranexamic acid in 3,000 high-risk cardiac surgical patients undergoing either re-operation for coronary heart bypass graft or aortic valve replacement, or combined valves or valve/CABG procedures.

-Jessica Merrill (j.merrill@elsevier.com)

Trasylol Re-Examination To Follow After Bayer Halts Enrollment In BART Study

More from Archive

More from Pink Sheet